Z-1284-2023 Class II Ongoing
FDA device recall Z-1284-2023 was initiated by Biomet, Inc. on February 6, 2023 and is designated Class II. Reason for recall: The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner. The recall status is ongoing. Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2023
- Initiation Date
- February 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
Reason for Recall
The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
Distribution Pattern
US Distribution to states of: AZ, FL, GA, MI, NE, and TX.
Code Information
UDI: (01)00880304703506(17)321128(10)65731960; Lot Number: 65731960